Frank Andersohn, Pedro Such, Michael Jan, Uwa Kalu, Jessica McDonough, Jonas Reinold, Oliver Riedel, Gianluca Trifirò, Valentina Ientile, Michele Tari, Maurizio Pastorello, Alejandro Arana, Joan Forns, Katja M Hakkarainen, Leyla Nunez, Kristian Tore Jørgensen, Jacob Simonsen, Murat Yildirim
{"title":"每月一次阿立哌唑治疗的患者使用抗胆碱能药物的频率：一项使用欧洲卫生保健数据库的2年队列研究","authors":"Frank Andersohn, Pedro Such, Michael Jan, Uwa Kalu, Jessica McDonough, Jonas Reinold, Oliver Riedel, Gianluca Trifirò, Valentina Ientile, Michele Tari, Maurizio Pastorello, Alejandro Arana, Joan Forns, Katja M Hakkarainen, Leyla Nunez, Kristian Tore Jørgensen, Jacob Simonsen, Murat Yildirim","doi":"10.1177/20451253251368010","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Extrapyramidal symptoms (EPS) in association with the long-acting, injectable, atypical antipsychotic aripiprazole once monthly (AOM) have been observed in clinical trials, but information on EPS requiring treatment with anticholinergic drugs in clinical practice is limited.</p><p><strong>Objectives: </strong>The objective of this European post-authorisation safety study (PASS) was to assess the risk of EPS-related events, as defined by dispensings of anticholinergic drugs, linked to the use of AOM in routine clinical practice.</p><p><strong>Design: </strong>This European cohort study was based on healthcare databases from Germany (German Pharmacoepidemiological Research Database GePaRD), Italy (Caserta and Palermo healthcare claims databases), and Sweden (National health registers). New users of AOM were followed from their first dispensing for a maximum of 2 years.</p><p><strong>Methods: </strong>Primary study outcome was an EPS-related event, defined as the first dispensing of an anticholinergic drug. The crude incidence rate (IR) and the cumulative incidence of EPS-related events were estimated. Cox proportional hazard regression modelling was performed to further investigate the effect of potential risk factors for the occurrence of EPS-related events.</p><p><strong>Results: </strong>A total of <i>N</i> = 1748 patients were eligible for inclusion into the primary study populations (Germany <i>N</i> = 629; Italy <i>N</i> = 519; Sweden <i>N</i> = 600). IRs of EPS-related events per 100 patient years were highest in Italy (IR = 18.4; 95% confidence interval (CI) 15.3-22.1), followed by Sweden (IR = 7.7; 95% CI 5.8-10.2) and Germany (IR = 3.4; 95% CI 2.4-4.6). Rates were highest during the first 30 days after treatment initiation. Cumulative incidences after 2 years of treatment were 27.8% (Italy), 11.5% (Sweden), and 10.0% (Germany). Diabetes and previous antipsychotic drug use were identified as risk factors for EPS-related events.</p><p><strong>Conclusion: </strong>In this observational study, incidence rates of EPS-related events, defined as the first dispensing of an anticholinergic drug during follow-up, were compatible with the known safety profile of AOM but showed substantial regional variation.</p><p><strong>Trial registration: </strong>EU PAS number EUPAS21056.</p>","PeriodicalId":23127,"journal":{"name":"Therapeutic Advances in Psychopharmacology","volume":"15 ","pages":"20451253251368010"},"PeriodicalIF":4.0000,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398657/pdf/","citationCount":"0","resultStr":"{\"title\":\"Frequency of anticholinergic drug use in patients treated with aripiprazole once-monthly: a 2-year cohort study using European healthcare databases.\",\"authors\":\"Frank Andersohn, Pedro Such, Michael Jan, Uwa Kalu, Jessica McDonough, Jonas Reinold, Oliver Riedel, Gianluca Trifirò, Valentina Ientile, Michele Tari, Maurizio Pastorello, Alejandro Arana, Joan Forns, Katja M Hakkarainen, Leyla Nunez, Kristian Tore Jørgensen, Jacob Simonsen, Murat Yildirim\",\"doi\":\"10.1177/20451253251368010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Extrapyramidal symptoms (EPS) in association with the long-acting, injectable, atypical antipsychotic aripiprazole once monthly (AOM) have been observed in clinical trials, but information on EPS requiring treatment with anticholinergic drugs in clinical practice is limited.</p><p><strong>Objectives: </strong>The objective of this European post-authorisation safety study (PASS) was to assess the risk of EPS-related events, as defined by dispensings of anticholinergic drugs, linked to the use of AOM in routine clinical practice.</p><p><strong>Design: </strong>This European cohort study was based on healthcare databases from Germany (German Pharmacoepidemiological Research Database GePaRD), Italy (Caserta and Palermo healthcare claims databases), and Sweden (National health registers). New users of AOM were followed from their first dispensing for a maximum of 2 years.</p><p><strong>Methods: </strong>Primary study outcome was an EPS-related event, defined as the first dispensing of an anticholinergic drug. The crude incidence rate (IR) and the cumulative incidence of EPS-related events were estimated. Cox proportional hazard regression modelling was performed to further investigate the effect of potential risk factors for the occurrence of EPS-related events.</p><p><strong>Results: </strong>A total of <i>N</i> = 1748 patients were eligible for inclusion into the primary study populations (Germany <i>N</i> = 629; Italy <i>N</i> = 519; Sweden <i>N</i> = 600). IRs of EPS-related events per 100 patient years were highest in Italy (IR = 18.4; 95% confidence interval (CI) 15.3-22.1), followed by Sweden (IR = 7.7; 95% CI 5.8-10.2) and Germany (IR = 3.4; 95% CI 2.4-4.6). Rates were highest during the first 30 days after treatment initiation. Cumulative incidences after 2 years of treatment were 27.8% (Italy), 11.5% (Sweden), and 10.0% (Germany). Diabetes and previous antipsychotic drug use were identified as risk factors for EPS-related events.</p><p><strong>Conclusion: </strong>In this observational study, incidence rates of EPS-related events, defined as the first dispensing of an anticholinergic drug during follow-up, were compatible with the known safety profile of AOM but showed substantial regional variation.</p><p><strong>Trial registration: </strong>EU PAS number EUPAS21056.</p>\",\"PeriodicalId\":23127,\"journal\":{\"name\":\"Therapeutic Advances in Psychopharmacology\",\"volume\":\"15 \",\"pages\":\"20451253251368010\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2025-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398657/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Psychopharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/20451253251368010\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Psychopharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20451253251368010","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Frequency of anticholinergic drug use in patients treated with aripiprazole once-monthly: a 2-year cohort study using European healthcare databases.
Background: Extrapyramidal symptoms (EPS) in association with the long-acting, injectable, atypical antipsychotic aripiprazole once monthly (AOM) have been observed in clinical trials, but information on EPS requiring treatment with anticholinergic drugs in clinical practice is limited.
Objectives: The objective of this European post-authorisation safety study (PASS) was to assess the risk of EPS-related events, as defined by dispensings of anticholinergic drugs, linked to the use of AOM in routine clinical practice.
Design: This European cohort study was based on healthcare databases from Germany (German Pharmacoepidemiological Research Database GePaRD), Italy (Caserta and Palermo healthcare claims databases), and Sweden (National health registers). New users of AOM were followed from their first dispensing for a maximum of 2 years.
Methods: Primary study outcome was an EPS-related event, defined as the first dispensing of an anticholinergic drug. The crude incidence rate (IR) and the cumulative incidence of EPS-related events were estimated. Cox proportional hazard regression modelling was performed to further investigate the effect of potential risk factors for the occurrence of EPS-related events.
Results: A total of N = 1748 patients were eligible for inclusion into the primary study populations (Germany N = 629; Italy N = 519; Sweden N = 600). IRs of EPS-related events per 100 patient years were highest in Italy (IR = 18.4; 95% confidence interval (CI) 15.3-22.1), followed by Sweden (IR = 7.7; 95% CI 5.8-10.2) and Germany (IR = 3.4; 95% CI 2.4-4.6). Rates were highest during the first 30 days after treatment initiation. Cumulative incidences after 2 years of treatment were 27.8% (Italy), 11.5% (Sweden), and 10.0% (Germany). Diabetes and previous antipsychotic drug use were identified as risk factors for EPS-related events.
Conclusion: In this observational study, incidence rates of EPS-related events, defined as the first dispensing of an anticholinergic drug during follow-up, were compatible with the known safety profile of AOM but showed substantial regional variation.
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Therapeutic Advances in Psychopharmacology delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of psychopharmacology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in psychopharmacology, providing a forum in print and online for publishing the highest quality articles in this area.
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